The Boston Globe
Biotech firm suggests a stem-cell bank
By Anthony Shadid, Globe Staff, 8/17/2001

BresaGen Inc., one of three companies to have disclosed
their ownership of embryonic stem cells, will urge the
National Institutes of Health to establish a stem-cell bank
and oversee management and distribution to researchers.

The company's proposal, which would go far beyond what
the NIH has said it plans to do, underscores the uncertainty
within the biotech industry that has followed President Bush's
decision to sanction federal funding for the work.

Dr. Allan Robins, the BresaGen chief scientific officer,
said the company lacks the infrastructure to handle stem-cell
requests that will probably number in the hundreds. Robins
and the company's chief executive, Dr. John Smeaton, will
present the proposal for a national stem-cell bank to NIH
officials next week.

''We'd like to see some quasi government body set up
for the distribution of these cells,'' Robins said from the
company's US headquarters in Athens, Ga. ''If we start to
get inundated by queries about the cells, a lot of our time
and effort will be diverted into just making sure that
technology and the cells are transferred to people.''

The NIH said yesterday it is planning a far less ambitious
registry, which would list the stem cells available and contact
information to obtain them. ''We really have done no thinking
about a repository,'' said Lana Skirboll, the agency's associate
director of science policy.

Skirboll said that so far, only BresaGen had raised concerns
with federal officials about an inability to distribute the cells.
But she said, ''I can imagine others might do that.'' And she
said the NIH will need to listen to difficulties that companies
and institutes, spread across three continents, might have in
providing the material and in producing enough of it.

BresaGen, whose parent office is in Adelaide, Australia,
derived four stem-cell lines over the past year but has yet
to distribute them. It is one of three companies identified
by the NIH as sources of what the agency estimates to be
60 lines in the world that would meet standards set out by
Bush last week.

But there is mounting uncertainty on how those cells would
be distributed.

In the United States, only the University of Wisconsin,
which holds the patents to embryonic stem cells first derived
in 1998, has a formal arrangement to provide them to
researchers. Other sources of stem cells, like the University
of California-San Francisco, have yet to establish any
procedures.

Adding to the confusion, scientists and researchers are
familiar with fewer than half of the NIH's estimate of 60 lines.

The agency has said that, in addition to lines derived in the
United States and Israel, others are available in India, Sweden,
Singapore, and Australia. It has declined to disclose the
specific sources of those lines, citing private companies'
concerns over their confidential research.

The distribution of the cells will prove crucial to the eventual
success of embryonic stem-cell research, which remains in its
infancy. The lines, which can develop into any of the body's
more than 200 types of cells, hold promise for therapies to
treat heart disease, spinal cord injury, diabetes,
and Parkinson's and Alzheimer's diseases.

The NIH expects to begin issuing grants in January.
But for now, it will be up to scientists to obtain the cells
for their research.

''We're going to need help from the NIH or some other
foundation to allow the distribution of these cell lines,''
Robins said. ''Our infrastructure is not going to allow us
to offer the cell lines in a timely manner to hundreds of
different laboratories.''

For academic scientists, who are typically more involved
in the basic research funded by the NIH, BresaGen suggests
an actual bank for the cells: The agency would take
possession of stem cells, use its own resources to grow
them in numbers needed for research, handle the quality
control, and then oversee their distribution.

The material transfer agreement with researchers would be
standardized, probably giving the company that owns the
lines the first right to license any breakthroughs.

''We think that's a pretty fair deal,'' Robins said.

Anthony Shadid can be reached by e-mail at
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This story ran on page A3 of the Boston Globe on 8/17/2001.

SOURCE: The Boston Globe
http://www.boston.com/dailyglobe2/229/nation/Biotech_firm_suggests_a_stem_cell_bank+.shtml

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